Rheumatology Advisor speaks with Philip J. Schneider, MS, FASHP, chairman of the international advisory board of the Alliance for Safe Biologic Medicines and Mohamed A. Jalloh, PharmD, spokesman of the American Pharmacists Association about the pivotal role of pharmacists in biosimilar patient education and advocacy.
In August 2016, the US Food and Drug Administration (FDA) announced their approval of Erelzi®, a biosimilar version of Amgen’s Enbrel® (etanercept) to be manufactured by Novartis.1 The drug is the third biosimilar product–and the second one indicated for the treatment of rheumatic diseases–to receive FDA approval. In April 2016, they announced their approval of Inflectra®, Celltrion Inc’s biosimilar to Janssen Biotech Inc’s Remicade® (infliximab).2
The first biosimilar the FDA approved, Zarxio® by Sandoz, the biosimilar version of Amgen’s Neupogen®, was introduced to the US market in September 2015.3 Additionally, the FDA’s Arthritis Advisory Committee gave a unanimous vote in July recommending the approval of ABP 501 by Amgen, a biosimilar to AbbVie’s Humira® (adalimumab).4
“The introduction of biosimilars into the US marketplace is an opportunity to moderate costs related to traditionally expensive medications,” said Edward Li, PharmD, MPH, BCOP, associate professor at the University of New England College of Pharmacy, in a policy paper for the American Pharmacists Association.5 “Experience in Europe indicates that these products are therapeutically equivalent to their reference products and confer moderate savings,” he reported.
However, there remain several unresolved issues surrounding the use of biosimilars, as well as ongoing concerns regarding the cost and administrative burden associated with the original biologic disease-modifying antirheumatic drugs (DMARDs) on which the biosimilar products are modeled. For example, an analysis of Medicare Part D plans’ coverage of biologic DMARDs across the US found that while all plans cover at least one such medication, most require high-cost sharing with patients as well as prior authorization, which can be burdensome to physicians and pharmacists.6
Pharmacists will have an essential role in integrating these biosimilars into practice and staying abreast of the latest policy and practice updates as they unfold. “Further, survey studies indicate that more education is needed about biosimilars,” and “pharmacists are also likely to take the lead in educating other health care providers and patients regarding biosimilars within their respective practices,” according to Dr Li’s paper.
To gain insight into these issues from the pharmacist’s perspective, Rheumatology Advisor interviewed Philip J. Schneider, MS, FASHP, professor and associate dean for academic and professional affairs for the College of Pharmacy at the Phoenix Biomedical Campus of the University of Arizona and Mohamed A. Jalloh, PharmD, assistant professor of clinical sciences at Touro University California College of Pharmacy, ambulatory clinical pharmacist at OLE Health in Napa, California, and spokesman of the American Pharmacists Association. They offered their thoughts on several pertinent topics.
The Recent and Pending FDA Approval of Several Biosimilars
Prof Schneider: The cost of biologics has been and will continue to be a challenge for [ insurance companies] ] who need to manage their costs, and for patients who are increasingly sharing the cost of prescription medications. Increased availability of biosimilars offer the potential for price competition that will reduce the costs of these important new medications.
Dr Jalloh: These approvals will make it easier for patients to afford biologic medications. As drug costs remain a big issue today, I commend the biosimilar manufacturers for helping to make the medications more affordable by creating greater competition.
Therapeutic Interchange vs Therapeutic Substitution
Prof Schneider: Hospital pharmacists createtherapeutic interchange programs in collaboration with the medical staff through pharmacy and therapeutics committees. This is a process by which the medical staff working with the pharmacy staff review, appraise and select those medications most suitable for use in the hospital. This may involve selecting one of several different medications that can be used interchangeably to simplify choices and reduce costs.
Therapeutic substitution is different–it will require that the FDA decide which biosimilars can be substituted by a pharmacist without advanced approval by the prescriber. The FDA has not classified any of the recently approved biosimilars as interchangeable.7 Pharmacy benefit managers (PBM) are pushing this independently by only including certain biosmilars on their formularies, presumably by getting discounts or rebates.
Dr Jalloh: Therapeutic substitution with biologics is a little different than substituting for generic medications. Common brand name medications can be substituted for their generic ones since their active ingredient share the same chemical structure, among other things. However, biosimilars must undergo additional tests to be considered interchangeable like generic medications for their brand counterpart. Without a biologic medication being labeled as “interchangeable,” pharmacists will find it difficult to automatically substitute for a biosimilar.
Insurance Approval Process for Biosimilars
Dr Jalloh: Since biosimilars undergo rigorous tests to validate, they are comparable in safety and efficacy and more affordable, therefore I suspect insurance policies will be motivated to cover them.
Prof Schneider: Non-formulary choices will probably require prior authorization and cost sharing in the form of higher co-pays for the patient. This will delay care, take pharmacist and prescriber time, and increase cost to patients.
Improving the Communication Between Rheumatologists and Pharmacists Regarding Biologics
Dr Jalloh: Pharmacists should continue to clarify with rheumatologists if they would like to prescribe a brand name biologic, despite the availability of a comparable biosimilar.
Prof Schneider: Collaborative practice arrangements where physicians delegate defined responsibilities to pharmacists are now legal in most states. Partnerships between individual rheumatologists and pharmacists can prospectively address some of the administrative and clinical barriers to the use of biologics. This is obviously easier in the hospital and health-system setting, but is also possible with community pharmacists. This may be easier with an independent community pharmacist or with newly emerging specialty pharmacies.
Pharmacist Advocacy for Biologic Disease-Modifying Antirheumatic Drugs
Prof Schneider: These are breakthrough therapies and are to be celebrated as therapeutic advances despite the challenges of administrative requirements by health plans and challenges managing their high costs. Pharmacists can be helpful in meeting these challenges by working with prescribers and patients.
Dr Jalloh: Pharmacists should continue to help inform rheumatologists and patients regarding available biosimilars to help improve access to them via continued medical education materials or presentations. Also, we should continue to reach out to our elected officials to help enact laws that make access to biosimilar substitutions more feasible.
Summary and Clinical Applicability
As newly approved biosimilars hit the US market, pharmacists will have a pivotal role in their integration into clinical practice and in physician and patient education on relevant issues.
Dr Jalloh and Prof Schneider report no relevant financial disclosures.
- US Food & Drug Administration. FDA News Release: FDA approves Erelzi, a biosimilar to Enbrel. Retrieved 9/9/16 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm
- US Food & Drug Administration. FDA News Release: FDA approves Inflectra, a biosimilar to Remicade. Retrieved 9/9/16 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494227.htm
- US Food & Drug Administration. FDA News Release: FDA approves first biosimilar product Zarxio. Retrieved 9/9/16 from http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm436648.htm
- Clarke T. FDA panel backs Amgen copy of AbbVie arthritis drug Humira. Reuters. Retrieved on 7/25/16 from http://mobile.reuters.com/article/healthcareSector/idUSKCN0ZS2NC
- Li E. Biologic, Biosimilar, and Interchangeable Biologic Drug Products Background Paper Prepared for the 2015–2016 APhA Policy Committee. Retrieved 9/9/16 from https://www.pharmacist.com/sites/default/files/files/Biosimilar%20Policy%20Background%20Paper%20-%20FINAL.PDF
US Food & Drug Administration. Information for Healthcare Professionals (Biosimilars). Retrieved 9/9/16 from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241719.htm